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HCFC-123) CAS No 1,1-Dichloro-2,2,2-trifluoroethane (HCFC-123) CAS No. 306-83-2 (Third Edition) JACC No. 47 ISSN-0773-6339-47 Brussels, May 2005 1,1-Dichloro-2,2,2-trifluoroethane (HCFC-123) ECETOC JACC REPORT No. 47 © Copyright – ECETOC European Centre for Ecotoxicology and Toxicology of Chemicals 4 Avenue E. Van Nieuwenhuyse (Bte 6), B-1160 Brussels, Belgium. All rights reserved. No part of this publication may be reproduced, copied, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without the prior written permission of the copyright holder. Applications to reproduce, store, copy or translate should be made to the Secretary General. ECETOC welcomes such applications. Reference to the document, its title and summary may be copied or abstracted in data retrieval systems without subsequent reference. The content of this document has been prepared and reviewed by experts on behalf of ECETOC with all possible care and from the available scientific information. It is provided for information only. ECETOC cannot accept any responsibility or liability and does not provide a warranty for any use or interpretation of the material contained in the publication. ECETOC JACC No. 47 1,1-Dichloro-2,2,2-trifluoroethane (HCFC-123) 1,1-Dichloro-2,2,2-trifluoroethane (HCFC-123) CAS No. 306-83-2 (Third Edition) CONTENTS EXECUTIVE SUMMARY 1 THE ECETOC SCHEME FOR THE JOINT ASSESSMENT OF COMMODITY CHEMICALS 2 LIST OF SPECIAL ABBREVIATIONS 3 1. SUMMARY AND CONCLUSIONS 4 2. IDENTITY, PHYSICAL AND CHEMICAL PROPERTIES, ANALYTICAL METHODS 8 2.1 Identity 8 2.2 EU classification and labelling 8 2.3 Physical and chemical properties 9 2.4 Conversion factors 10 2.5 Analytical methods 10 3. PRODUCTION AND USE 11 3.1 Production 11 3.2 Use 11 4. ENVIRONMENTAL DISTRIBUTION, TRANSFORMATION AND IMPACT 12 4.1 Sources 12 4.2 Environmental distribution 12 4.3 Atmospheric lifetime 13 4.4 Ozone depleting potential 13 4.5 Global warming potential 13 4.6 Tropospheric ozone formation 14 4.7 Degradation mechanism and products 14 4.8 Contribution of degradation products to environmental chloride, fluoride and trifluoroacetate and 16 to the acidity of rainwater 4.9 Biodegradability 16 5. ENVIRONMENTAL LEVELS AND HUMAN EXPOSURE 18 5.1 Environmental levels 18 5.2 Consumer exposure 18 5.3 Occupational exposure 18 ECETOC JACC No. 47 1,1-Dichloro-2,2,2-trifluoroethane (HCFC-123) 6. EFFECTS ON ORGANISMS IN THE ENVIRONMENT 21 6.1 Aquatic toxicity 21 6.2 Aquatic organisms 21 6.3 Terrestrial organisms 22 7. KINETICS AND METABOLISM 23 7.1 Animal studies 23 7.1.1 Absorption 23 7.1.2 Distribution 25 7.1.3 Metabolism 25 7.1.4 Elimination 29 7.1.5 Covalent binding 30 7.1.6 Summary 32 7.2 Human studies 33 8. EFFECTS ON EXPERIMENTAL ANIMALS AND IN VITRO TEST SYSTEMS 34 8.1 Acute toxicity 34 8.1.1 Oral toxicity 34 8.1.2 Dermal toxicity 34 8.1.3 Inhalation toxicity 34 8.1.4 Cardiac sensitisation 36 8.2 Skin, respiratory tract and eye irritation, sensitisation 37 8.2.1 Skin irritation and sensitisation 37 8.2.2 Eye irritation 37 8.3 Subacute/subchronic toxicity 37 8.4 Mutagenicity and cell transformation 41 8.4.1 In vitro 41 8.4.2 In vivo 43 8.4.3 Conclusion 45 8.5 Chronic toxicity and carcinogenicity 45 8.5.1 Discussion and assessment 51 8.6 Embryotoxicity, teratology and reproductive performance 55 8.6.1 Embryotoxicity and teratology 55 8.6.2 Reproductive performance 55 8.7 Special studies 58 8.7.1 Neurotoxicity 58 8.7.2 Endocrine evaluations 59 8.7.3 Peroxisome proliferation and hypolipidemia 60 8.7.4 In vitro studies in testicular cell cultures 63 8.7.5 Other investigations 63 ECETOC JACC No. 47 1,1-Dichloro-2,2,2-trifluoroethane (HCFC-123) 9 EFFECTS ON HUMANS 65 9.1 General population exposure 65 9.2 Occupational exposure 65 10. BIBLIOGRAPHY 67 10.1 References quoted 67 10.2 References not quoted 79 APPENDIX A: CRITERIA FOR RELIABILITY CATEGORIES 82 APPENDIX B: NAMING AND NUMBERING SYSTEM FOR FLUOROCARBON COMPOUNDS 83 APPENDIX C: CONVERSION FACTORS FOR VAPOUR CONCENTRATIONS IN AIR 86 MEMBERS OF THE TASK FORCE 87 MEMBERS OF THE SCIENTIFIC COMMITTEE 89 ECETOC JACC No. 47 1,1-Dichloro-2,2,2-trifluoroethane (HCFC-123) ECETOC JACC No. 47 1,1-Dichloro-2,2,2-trifluoroethane (HCFC-123) EXECUTIVE SUMMARY This report has been produced as part of the ECETOC Joint Assessment of Commodity Chemicals (JACC) programme. It updates an earlier ECETOC review a and presents a critical evaluation of the available toxicity and ecotoxicity data on 1,1-dichloro-2,2,2-trifluoroethane (HCFC-123), including results of new toxicological studies conducted by the Programme for Alternative Fluorocarbon Toxicity Testing (PAFT) b. HCFC-123 is a volatile liquid that is used, for example, as a refrigerant in air-conditioning installations and as an intermediate in the production of various chemicals. HCFC-123 is a transitional replacement (to be phased out by 2020) for chloro- and bromo-fluorocarbons. It has a low potential for ozone depletion (2% of that of CFC-11, trichlorofluoromethane) and global warming (76 relative to carbon dioxide; this compares to 4,000 for CFC-11). Any HCFC-123 released to the environment will rapidly volatilise to the atmosphere, where it will be slowly degraded, mainly to trifluoroacetic acid, which will partition into water and possibly accumulate there, although predicted concentrations are below toxic thresholds. HCFC-123 is not readily biodegradable, but is not likely to bio-concentrate in fish and other aquatic organisms. It is slightly to moderately toxic to fish, invertebrates, and algae. Thus, HCFC-123 is unlikely to pose a significant hazard to the aquatic environment; it is also not persistent in water. HCFC-123 has a low toxicity in laboratory animals upon single brief exposure to the liquid or vapour. The liquid is not irritant or sensitising to the skin, but produces eye irritation. For humans, the most relevant critical effects from single, brief single exposure to HCFC-123, such as from the discharge of a fire extinguisher, are depression of the central nervous system and increased likelihood of cardiac arrhythmia. Repeated exposure to HCFC-123 may yield liver lesions. In reproductive toxicity studies in animals, the growth of neonates was retarded, probably because the milk of the dams contained trifluoroacetic acid, the main metabolite of HCFC-123. HCFC-123 is not genotoxic in vivo, although there was clastogenetic activity at high doses in vitro. HCFC-123 caused statistically significant increases in benign tumours in rat liver, testis and pancreas. The formation of liver tumours can be linked with the rodent-specific peroxisome proliferation potential of HCFC-123, while the testicular tumours may have resulted from enhanced hormonal disturbances in senescent rats. Thus, the hepatic and testicular tumours are not relevant for human health hazard assessment. The mechanism of pancreatic acinar cell tumour formation is not understood, and the significance of those tumours for humans remains uncertain. a ECETOC. 1996. Joint assessment of Commodity Chemicals report No. 33 b A cooperative research effort (1987-2000) sponsored by 16 of the leading CFC producers [http://www.afeas.org/paft/] ECETOC JACC No. 47 1 1,1-Dichloro-2,2,2-trifluoroethane (HCFC-123) THE ECETOC SCHEME FOR THE JOINT ASSESSMENT OF COMMODITY CHEMICALS This report has been produced as part of the ECETOC Joint Assessment of Commodity Chemicals (JACC) programme for preparing critical reviews of the toxicology and ecotoxicology of selected existing industrial chemicals. In the programme, commodity chemicals (i.e. those produced in large tonnage by several companies and having widespread and multiple use) are jointly reviewed by experts from a number of companies with knowledge of the chemicals. Only the chemical itself is considered in a JACC review; products in which it appears as an impurity are not normally taken into account. This document presents a critical evaluation of the toxicology and ecotoxicology of 1,1-dichloro- 2,2,2-trifluoroethane (HCFC-123) (CAS No. 306-83-2). Where relevant, the Task Force has graded the studies by means of a ‘code of reliability’ (CoR) (Appendix A) to reflect the degree of confidence that can be placed on the reported results. ECETOC JACC No. 47 2 1,1-Dichloro-2,2,2-trifluoroethane (HCFC-123) LIST OF SPECIAL ABBREVATIONS ALD Approximate lethal dose ALP Alkali phosphatase ALT Alanine transferase AST Aspartate transaminase CAS Chemical Abstracts Service CCK Cholecystokinin CFC Chlorofluorocarbon CNS Central nervous system CoR Code fo reliability EQC Equilibrium criterion GGT γ-glutamyl transpeptidase GWP Global warming potential HCFC Hydrochlorofluorocarbon HCG Human chorionic gonadotropin HFC Hydrofluorocarbon hPa Hectopascal HPLC High-pressure liquid chromatography i.p. Intraperitoneal ITH Integration time horizon JACC Joint Assessment of Commodity Chemicals Km Michaelis-Menten constant LDHX Lactate dehydrogenase-X LHRH Luteinising hormone-releasing hormone LOAEL Lowest-observed-adverse-effect level MHA Methaemalbumin NOAEL No-observed-adverse-effect level NOEC No-observed-effect concentration NOEL No-observed-effect level ODPs Ozone depleting potentials PAFT Programme for Alternative Fluorocarbon Toxicity Testing PPAR Peroxisome proliferator activated receptor ppb Parts per billion ppm Parts per million ppt Parts per trillion TFA Trifluoroacetic acid UDS Unscheduled DNA synthesis Vmax Maximal metabolic rate; velocity at maximal concentration of substrate WY Wyeth ECETOC JACC No. 47 3 1,1-Dichloro-2,2,2-trifluoroethane (HCFC-123) 1. SUMMARY AND CONCLUSIONS 1,1-Dichloro-2,2,2-trifluoroethane (HCFC-123 a) is a non-combustible, volatile colourless liquid with a slight ether odour.
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